Bayer's Diabetic Macular Edema Drug Receives CHMP Positive Opinion

Bayer Healthcare announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for approval in the EU of the company’s aflibercept solution for injection into the eye to treat vision damage caused by diabetic macular edema.

Aflibercept solution for injection is a recombinant fusion protein comprising portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept binds VEGF-A and placental growth factor (PlGF) and discourages the binding and activation action of their cognate VEGF receptors, which has been linked to the growth of abnormal blood vessels in the eye and the development of edema.

The recommended dose for aflibercept solution is 2 mg or equivalent to 50 microliters for injection into the eye. The company’s submission is based on data from the positive results of the Phase 3 VIVID-DME and VISTA-DME studies which showed aflibercept solution for injection into the eye 2 mg every other month quickly improved and sustained visual acuity better than treatment with laser photocoagulation.

Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “Early diagnosis of DME is critical. If DME is not treated rigorously, there is a high risk of DME leading to blindness. About half of the patients lose more than two lines of vision within two years of diagnosis without treatment, which can impact their ability to perform important daily activities such as working and driving.”

Diabetic macular edema (DME) is a common complication of Diabetic Retinopathy. DME is the most frequent cause of blindness among young and mid-aged adults in most developed countries. Up to 7 percent of all diabetic patients are expected to develop DME in their lifetime while around 6.2 million people with DME are considered treatable.

The company said it is expecting a decision from the European Commission for aflibercept solution in the next few months.